ES3042426T3 - Glaucoma treatment device - Google Patents

Abstract

The methods and devices are adapted for implantation in the eye. An incision is made in the cornea, and a shunt is inserted through the incision into the anterior chamber of the eye. The shunt includes a fluid conduit. The shunt is passed along a path from the anterior chamber through the scleral spur of the eye into the suprachoroidal space and positioned so that a first portion of the fluid conduit communicates with the anterior chamber and a second portion communicates with the suprachoroidal space, thus providing a fluid conduit between the suprachoroidal space and the anterior chamber.

Description

[0001] DESCRIPTION

[0002] Device for the treatment of glaucoma

[0004] PRIOR ART STATEMENT

[0006] This disclosure generally relates to methods and devices for use in the treatment of glaucoma. The mechanisms that cause glaucoma are not fully understood. Glaucoma is known to produce abnormally high pressure in the eye, which damages the optic nerve. Over time, the increased pressure can lead to optic nerve damage, which can result in blindness. Treatment strategies have focused on keeping intraocular pressure low to preserve as much vision as possible for the remainder of the patient's life.

[0008] Previous treatment has included the use of drugs that reduce intraocular pressure through various mechanisms.

[0009] The glaucoma drug market is approximately two billion dollars. The large market is primarily due to the lack of effective, long-lasting, and uncomplicated surgical alternatives.

[0010] Unfortunately, drug treatments are in dire need of improvement, as they can cause adverse side effects and often fail to adequately control intraocular pressure. Furthermore, patients are frequently negligent in adhering to appropriate drug treatment regimens, leading to poor compliance and further symptom progression.

[0012] Regarding surgical procedures, one way to treat glaucoma is to implant a drainage device, or shunt, in the eye. The drainage device works to drain aqueous humor from the anterior chamber and thus reduce intraocular pressure. The drainage device is usually implanted using an invasive surgical procedure.

[0013] One of these procedures involves surgically creating a flap in the sclera. The flap is folded back to form a small cavity, and a shunt is inserted into the eye through the flap. This procedure can be quite traumatic because the implants are large and can lead to various adverse effects such as infection and scarring, resulting in the need for further surgery.

[0015] The following references describe various devices and procedures for treating glaucoma: U.S. Patent 6,827,700 to Lynch, 6,666,841 to Bergheim, 6,508,779 to Suson, 6,544,208 to Ethier, 5,601,094 to

[0016] Reiss, 6.102.045 of Nordquist, United States Patent Application 2002/0156413 of Williams, 2002/0143284 of

[0017] Tu , 2003/0236483 de Ren , 2002/0193725 de Odrich , 2002/0165478 de Gharib , 2002/0133168 de Smedley , 2005/0107734,2004/0260228 de Lynch , 2004/0102729 to Haffuer , 2004/0015140 to Shields , 2004/0254521 to Simon and 2004/0225250 to Yablonski .

[0019] US-A1-2002/013168 describes an apparatus for placing a fluid shunt through the trabecular meshwork and into Schlemm's canal. US-A1-2004/0050392 describes surgical methods and devices for placing a stent implant through the trabecular meshwork. WO-A2-01/78656 describes shunting a diseased trabecular meshwork with a seton implant. WO-A2-2005/107664 describes an apparatus for forming a tissue tract and creating a fluid pathway from Schlemm's canal to the suprachoroidal space. WO-A2-02/080811 describes a self-trepanning stent for glaucoma. WO-A1-99/26567 describes an implant and insertion device having a retractable wire. US-A1-2004/0015140 describes an implantable ophthalmic shunt in an eye having an elongated body with an insertion head and a shoulder surface. US-A1-2005/0266047 describes intraocular stents configured to span between the anterior chamber and Schlemm's canal. WO-A2-02/102274 describes an aqueous transport element for positioning with an inlet end within an anterior chamber and an outlet end in the vicinity of a trabecular meshwork.

[0021] Current devices and procedures for treating glaucoma have drawbacks and moderate success rates. The procedures are highly traumatic to the eye and also require very precise surgical skills, such as correctly placing the drainage device in the proper location. In addition, devices that drain fluid from the anterior chamber into a subconjunctival bleb beneath a scleral flap are prone to infection and can become occluded and cease functioning. This may necessitate a second operation to remove the device and place another, or it may lead to further surgeries. In light of the above, there is a need for improved devices and methods for treating glaucoma.

[0023] BRIEF DESCRIPTION

[0025] The invention is set forth in the independent claim, and preferred features are set forth in the dependent claims. Devices and methods for the treatment of eye disease such as glaucoma are disclosed. A shunt is placed in the eye, where the shunt provides a fluid pathway for the flow or drainage of aqueous humor from the anterior chamber into the suprachoroidal space. The shunt is implanted in the eye using a delivery system that employs a minimally invasive procedure, as described below. By guiding the fluid directly into the supraciliary or suprachoroidal space rather than to the surface of the eye, complications commonly encountered with conventional glaucoma surgery should be avoided. Diverting the flow of aqueous fluid directly into the supraciliary or suprachoroidal space should minimize scarring, since the angle region is populated by a single line of non-proliferating trabecular cells. Diverting the aqueous flow directly

[0026] to the supraciliary or suprachoroidal space should minimize hypotony and also potentially eliminate complications such as endophthalmitis and leakage, since an external filtering bleb is not the goal of the surgery. The device described herein is designed to enhance aqueous outflow through the normal outflow system of the eye with minimal to no complications. Any of the procedures and devices described herein may be performed in conjunction with other therapeutic procedures, such as laser iridotomy, laser iridoplasty, and goniosynechialysis (a cyclodialysis procedure).

[0028] In one aspect, a glaucoma treatment device is described comprising an elongated member having a flow pathway, at least one inlet port communicating with the flow pathway, and an outlet port communicating with the flow pathway. The inlet port and outlet port are positioned such that the flow pathway provides a fluid route between an anterior chamber and a suprachoroidal space when the elongated member is implanted in the eye.

[0029] Among the methods provided herein is a method for implanting an ocular device in the eye, comprising making an incision in the cornea of the eye; inserting a shunt through the incision into the anterior chamber of the eye, wherein the shunt includes a fluid passage; passing the shunt along a pathway from the anterior chamber through the scleral spur of the eye to the suprachoroidal space; and placing the shunt in a first position such that a first portion of the fluid passage communicates with the anterior chamber and a second portion of the fluid passage communicates with the suprachoroidal space to provide a fluid passage between the suprachoroidal space and the anterior chamber.

[0031] In other embodiments, a method for implanting an ocular device in the eye is provided herein, comprising making an incision in the cornea of the eye; inserting a shunt through the incision into the anterior chamber of the eye, wherein at least a portion of the shunt can be opened to allow fluid flow along the shunt; passing the shunt along a pathway from the anterior chamber through the scleral spur of the eye to the suprachoroidal space; positioning the shunt in a first position such that a first portion of the shunt communicates with the anterior chamber and a second portion of the shunt communicates with the suprachoroidal space; and opening the shunt to allow fluid flow such that the shunt provides a fluid passage between the suprachoroidal space and the anterior chamber.

[0033] In other embodiments, a method for implanting an ocular device in the eye is provided herein, comprising making an incision in the cornea of the eye; mounting a shunt on an insertion device wherein at least a portion of the shunt or insertion device has a curvature that matches the curvature of the eye; inserting the shunt through the incision into the anterior chamber of the eye wherein the shunt includes a fluid passage; aiming the shunt relative to the suprachoroidal space such that the curvature of the shunt or insertion device aligns with the curvature of the eye; and inserting at least a portion of the shunt into the suprachoroidal space to provide a fluid passage between the suprachoroidal space and the anterior chamber.

[0035] In other embodiments, a method is provided for implanting an ocular device in the eye, comprising making an incision in the cornea of the eye; inserting a shunt through the incision into the anterior chamber of the eye, wherein the shunt includes a fluid passage; passing the shunt along a pathway from the anterior chamber through the scleral spur of the eye to the suprachoroidal space; and placing the shunt in a first position such that a first portion of the fluid passage communicates with the anterior chamber and a second portion of the fluid passage communicates with the suprachoroidal space to provide a fluid passage between the suprachoroidal space and the anterior chamber, wherein the shunt is preformed to place the first portion away from the iris.

[0037] In other embodiments, a method for implanting an ocular device in the eye is provided herein, comprising making an incision in the sclera of the eye; inserting a shunt through the incision into the suprachoroidal space of the eye, wherein the shunt includes a fluid passage; passing the shunt along a pathway from the suprachoroidal space through the scleral spur of the eye to the anterior chamber; and placing the shunt in a first position such that a first portion of the fluid passage communicates with the anterior chamber and a second portion of the fluid passage communicates with the suprachoroidal space to provide a fluid passage between the suprachoroidal space and the anterior chamber.

[0039] Also provided herein is a glaucoma treatment device comprising an elongated member having a flow pathway, at least one inlet port communicating with the flow pathway, and an outlet port communicating with the flow pathway, wherein the elongated member is adapted to be placed in the eye such that the inlet port communicates with the anterior chamber, the outlet port communicates with the suprachoroidal space, and at least a portion of the elongated member passes through the scleral spur to provide a fluid pathway between the anterior chamber and the suprachoroidal space when the elongated member is implanted in the eye.

[0041] In other embodiments, a glaucoma treatment device is provided herein, comprising an elongated member having a flow pathway, at least one inlet port communicating with the flow pathway, and an outlet port communicating with the flow pathway, wherein the elongated member is adapted to be placed in the eye such that the inlet port communicates with the anterior chamber and the outlet port communicates with the suprachoroidal space, wherein at least a portion of the elongated member includes an enlarged bulbous region adapted to form a space within the suprachoroidal space for fluid accumulation.

[0043] In another embodiment, a glaucoma treatment device is provided herein, comprising an elongated member having a flow pathway, at least one inlet port communicating with the flow pathway, and an outlet port communicating with the flow pathway, wherein the elongated member is adapted to be placed in the eye such that the inlet port communicates with the anterior chamber and the outlet port communicates with the suprachoroidal space, the elongated member having a first region and a second region, wherein the second region is adapted to transition from a first shape to a second shape while the first regions remain unchanged.

[0045] In another embodiment, a glaucoma treatment device is provided herein, comprising a curved member sized to fit within an angle between the cornea and iris of an eye; at least two legs extending outward from the curved member and shaped to extend into the suprachoroidal space, wherein at least one of the legs provides a pathway for fluid flow into the suprachoroidal space.

[0046] In other embodiments, a glaucoma treatment system is provided herein comprising an elongated member with a flow pathway, at least one inlet port communicating with the flow pathway and an outlet port communicating with the flow pathway, wherein the elongated member is adapted to be placed in the eye so that the inlet port communicates with the anterior chamber and the outlet port communicates with the suprachoroidal space, wherein at least a portion of the elongated member includes an enlarged bulbous region adapted to form a space within the suprachoroidal space for fluid accumulation within the suprachoroidal space; and an insertion device having an elongated applicator removably attached to the elongated member, the insertion device including an actuator that withdraws the elongated member from the applicator.

[0048] Other features and advantages will become apparent from the following description of various embodiments, which illustrate, by way of example, the principles of the invention.

[0050] BRIEF DESCRIPTION OF THE DRAWINGS

[0052] Figure 1 is a perspective, cross-sectional view of a portion of the eye showing the anterior and posterior chambers of the eye.

[0053] Figure 2 is a cross-sectional view of a human eye.

[0054] Figure 3A shows a first realization of any ocular shunt.

[0055] Figure 3B shows a branch formed by an elongated wick member through which the fluid can flow. Figure 3C shows a branch that combines a tube and a wick member.

[0056] Figure 4 shows the shunt that includes one or more retention structures.

[0057] Figure 5 shows an illustrative embodiment of a delivery system that can be used to insert the shunt into the eye.

[0058] Figure 6A shows another embodiment of a management system.

[0059] Figure 6B shows another embodiment of a management system.

[0060] Figures 6C and 6D show the administration system of Figure 6B during performance.

[0061] Figures 6E-6G show a distal region of the delivery system during various stages of actuation. Figure 6H shows a magnified view of an illustrative distal region of a delivery system applicator. Figure 7 shows a magnified view of a shunt end region.

[0062] Figure 8 shows another embodiment of the shunt where a plurality of holes are located in the side walls of the shunt.

[0063] Figure 9A shows another embodiment of the derivation that includes a fixed-size elongated portion and one or more expansion members.

[0064] Figure 9B shows an embodiment of the expansion members that are formed by separate prongs.

[0065] Figure 10 shows another embodiment of the shunt that includes a retention member located at the proximal end of the shunt.

[0066] Figure 11 shows an embodiment of the branch that includes one or more slots.

[0067] Figure 12 shows an embodiment of the shunt that includes a distal coil member.

[0068] Figure 13 shows a distal region of an embodiment of the shunt that includes a distal coil member and a tapered distal end.

[0069] Figure 14 shows a cross-sectional view of the eye and a viewing lens.

[0070] Figure 15A shows the delivery system positioned for penetration into the eye.

[0071] Figure 15B shows an embodiment in which the delivery system is connected to a power source. Figure 16 shows a magnified view of the anterior region of the eye with a portion of the delivery system positioned in the anterior chamber.

[0072] Figure 17 shows the distal tip of the applicator positioned within the suprachoroidal space.

[0073] Figure 18 shows a branch that has a skirt.

[0074] Figure 19 shows a branch that is equipped with a spiked skirt.

[0075] Figure 20 shows the skirted shunt placed in the eye.

[0076] Figure 21 shows a shunt implanted in the eye to provide a fluid pathway between the anterior chamber and the suprachoroidal space.

[0077] Figures 22 and 23 show derivations that include external fluid flow features.

[0078] Figures 24, 25A and 25B show a branch that includes an elongated outer member mounted on a plug member.

[0079] Figure 26 shows an embodiment of the bypass formed by a sponge-like flow member.

[0080] Figure 27 shows a branch like the one in Figure 26 that has an internal lumen.

[0081] Figure 28 shows an embodiment of the branch that includes a pair of anchor members located at opposite ends of the branch.

[0082] Figure 29 shows an end region of the branch that includes cuts.

[0083] Figure 30 shows an embodiment of the shunt with external sleeves.

[0084] Figure 31 shows another embodiment of the shunt with cuffs.

[0085] Figure 32 shows another realization of the derivation, which has a spiral structure.

[0086] Figures 33A, 33B and 34 show realizations of the shunt that include a grasping loop.

[0087] Figure 35 shows an embodiment of an elongated device with a handle that can be placed inside a lead. Figure 36 shows an embodiment of a spatula-shaped end region of a lead.

[0088] Figure 37 shows a shunt that has an atraumatic tip.

[0089] Figure 38 shows an embodiment in which the shunt includes a resilient region.

[0090] Figures 39, 40A and 40B show alternative realizations of the derivation.

[0091] Figure 41 shows an embodiment of the shunt with holes that communicate with an internal lumen.

[0092] Figures 42A, 42B and 43 show realizations of the shunt that include valve regions.

[0093] Figures 44 and 45 show realizations of the derivation that include one or more bulbous elements.

[0094] Figures 46 and 47 show embodiments of the bulbous element shunt positioned in the suprachoroidal space. Figure 48 shows an embodiment of the shunt that includes a bullet-shaped tip member.

[0095] Figure 49 shows an embodiment of a shunt that is mounted on a mandrel.

[0096] Figures 50 and 51A show realizations of leads that change shape after removal from a mandrel. Figure 51B shows another embodiment of a lead.

[0097] Figure 51C shows another realization of a derivation.

[0098] Figure 52 shows a shunt with a curved proximal region positioned in the eye.

[0099] Figure 53 shows a schematic frontal view of the upper region of a patient's face, including both eyes. Figures 54A and 54B show perspective and plan views of an illustrative insertion path of the applicator and shunt during shunt implantation in the eye.

[0100] Figures 55A to 55D show plan and perspective views of a management system inserted into the eye.

[0101] Figure 56 shows a plan view of an illustrative insertion track.

[0102] Figure 57 shows a perspective view of an alternative insertion pathway into the eye.

[0103] Figures 58A-58D show yet another route of insertion into the eye.

[0104] Figure 59 shows a shunt that has a dimensioned extension and is positioned so that a proximal end is located over an iris ridge.

[0105] Figure 60 shows a shunt with a curved extension placed in the eye.

[0106] Figure 61 shows another embodiment in which the shunt extends through the iris so that the proximal end and internal lumen of the shunt communicate with the posterior chamber.

[0107] Figures 62 and 63 show a transscleral insertion approach for the shunt.

[0109] Detailed description

[0111] Figure 1 is a perspective and cross-sectional view of a portion of the eye showing the anterior and posterior chambers. A shunt 105 is placed within the eye such that a proximal end 110 is located in the anterior chamber 115 and a distal end 120 is located in the suprachoroidal space (sometimes called the perichoroidal space). The shunt 105 is illustrated in Figure 1 as an elongated element having one or more internal lumens through which aqueous humor can flow from the anterior chamber 115 into the suprachoroidal space. Implementations of the shunt 105 with various structural configurations are described in detail below.

[0112] Illustrative eye anatomy

[0114] Figure 2 is a cross-sectional view of a human eye. The eye is generally spherical and is covered externally by the sclera S. The retina R lines the inner posterior half of the eye. The retina registers light and sends signals to the brain via the optic nerve. Most of the eye is filled and supported by the vitreous body, a transparent, gelatinous substance.

[0116] The elastic lens L is located near the front of the eye. The crystalline lens L provides focus adjustment and is suspended within a capsular bag of the ciliary body CB, which contains the muscles that change the focal length of the lens. A volume in front of the crystalline lens L is divided in two by the iris I, which controls the aperture of the lens and the amount of light reaching the retina. The pupil is an opening in the center of the iris I through which light passes. The volume between the iris I and the crystalline lens L is the posterior chamber PC. The volume between the iris I and the cornea is the anterior chamber AC. Both chambers are filled with a clear fluid known as the aqueous humor.

[0117] The ciliary body (CB) continuously forms aqueous humor in the posterior chamber (PC) by secretion from blood vessels. The aqueous humor flows around the lens (L) and iris (I) into the anterior chamber and exits the eye through the trabecular meshwork, a sieve-like structure located at the corner of the iris (I) and the eye wall (the corner is known as the iridocorneal angle). Some of the aqueous humor filters through the trabecular meshwork into Schlemm's canal, a small channel that drains into the ocular veins. A smaller portion re-enters the venous circulation after passing through the ciliary body and finally the sclera (the uveosclerotic pathway).

[0119] Glaucoma is a disease in which aqueous humor accumulates within the eye. In a healthy eye, the ciliary processes secrete aqueous humor, which then passes through the angle between the cornea and the iris. Glaucoma appears to result from a blockage in the trabecular meshwork. The blockage can be caused by the shedding of cells or other debris. When the aqueous humor does not drain properly from the obstructed meshwork, it accumulates and causes increased pressure in the eye, particularly in the blood vessels leading to the optic nerve. The high pressure on the blood vessels can lead to the death of retinal ganglion cells and, eventually, blindness.

[0121] Acute angle-closure glaucoma can occur in people born with a narrow angle between the iris and cornea (the anterior chamber angle). This is more common in people with farsightedness (farsightedness) (who see distant objects better than near ones). The iris can slip forward and suddenly close off the outflow of aqueous humor, followed by a sudden increase in pressure inside the eye.

[0123] Open-angle (chronic) glaucoma is by far the most common type of glaucoma. In open-angle glaucoma, the iris does not block the drainage angle as it does in acute glaucoma. Instead, the fluid outflow channels within the wall of the eye gradually narrow over time. The disease usually affects both eyes, and over the years, the consistently elevated pressure slowly damages the optic nerve.

[0125] Referral and administration system

[0127] Figure 3A shows a first embodiment of shunt 105. As mentioned, shunt 105 is an elongated member having a proximal end 110, a distal end 120, and a structure that allows fluid (such as aqueous humor) to flow along, through, or around the shunt. In the embodiment of Figure 3A, the elongated member includes at least one internal lumen 305 having at least one opening for fluid inlet and at least one opening for fluid outlet. In the embodiment of Figure 3A, the shunt includes a single opening at the proximal end 110 and a single opening at the distal end 120 that communicate with the internal lumen 305. However, shunt 105 may include various arrangements of openings communicating with the lumen(s), as described below.

[0129] Internal lumen 305 serves as a passage for aqueous humor flow through shunt 105 directly from the anterior chamber to the suprachoroidal space. Additionally, internal lumen 305 can be used to mount shunt 105 into a delivery system, as described below. Internal lumen 305 can also be used as a pathway for irrigation fluid to flow into the eye, typically for flushing or maintaining pressure in the anterior chamber, or to use the fluid to hydraulically create a dissection plane in or within the suprachoroidal space. In the embodiment of Figure 3A, shunt 105 has a substantially uniform diameter along its entire length, although the shunt diameter may vary along its length, as described below. Furthermore, although lead 105 is shown with a circular cross-section, the lead can have various cross-sectional shapes (such as oval or rectangular) and its cross-sectional shape can vary along its length. The cross-sectional shape can be selected to facilitate insertion into the eye.

[0131] The 105 shunt may include one or more features that aid in its correct positioning within the eye. For example, the shunt may have one or more visual, tomographic, echogenic, or radiopaque markers that can be used to assist in placement using any of the devices mentioned above tuned to their applicable marker system. When using the markers to correctly position the implant, the shunt is inserted into the suprachoroidal space until the marker is aligned with a relevant anatomical structure, for example, by visually identifying a marker on the anterior chamber portion of the shunt that aligns with the trabecular meshwork or scleral spur, so that an appropriate length of the shunt remains in the anterior chamber. Using ultrasound, an echogenic marker can indicate the location of the device within the suprachoroidal space. Any marker can be placed anywhere on the device to provide sensory feedback to the user regarding real-time placement, confirmation of placement, or during patient follow-up. Other structural features are described below.

[0133] The 105 shunt may also include structural features that help anchor or retain the implanted 105 shunt in the eye. For example, as shown in Figure 4, the 105 shunt may include one or more 410 retaining or retention structures, such as protrusions, wings, spikes, or prongs, that are lodged in the anatomy to retain the shunt in place. 410 retention structures may be deformable or rigid. 410 retention structures may be made of various biocompatible materials. For example, 410 retention structures may be made of thin 0.001" thick polyimide, which is flexible, thin 0.003" thick silicone elastomer, which is also flexible, or stainless steel or Nitinol. Alternatively, 410 retention structures could be polyimide rings. It should be noted that other materials can be used to manufacture the 410 retaining structures. The shape of the 410 retaining structures can vary. For example, Figure 4 shows the 410 retaining structures shaped like spikes, with the pointed edges of the spikes facing in opposite directions. In another embodiment, the 410 retaining structures can be rectangular, triangular, round, combinations thereof, or other shapes. Additional embodiments of 410 retaining structures are described below.

[0135] Other anchoring or retention features may be employed with the 105 lead. For example, one or more hairs, such as human hair or synthetic hairs made of polymers, elastomers, or metals, may be attached to the lead. The hairs may be glued or thermally bonded to the lead. If the hairs are made of polyimide, they may be attached to the lead by immersion and polymerized by heat and pressure if the immersion material is polyimide. The hairs may be secured to the lead by rings. Alternatively, the lead may have through-hole features through which the hairs may be passed and tied or knotted. The hairs may be overmolded onto the lead body. The hairs are positioned relative to the lead so that at least a portion of the hair extends outward from the lead to anchor within or against the eye tissue. This document describes various anchoring and retention features, and it should be noted that these features can be implemented in any of the derivation realizations described herein.

[0137] Retention features, such as wings or collars, can be manufactured by various methods. In one embodiment, the retention features may be inherent in the raw material from which the shunt is constructed. The shunt may be machined or laser-ablated from a unit rod or block of material, subtracting or removing the material, leaving behind the retention features.

[0139] Alternatively, the retention features may be manufactured as separate pieces and assembled onto the shunt. They may be attached to the shunt by a friction fit or secured with biocompatible adhesives. They may fit into grooves, holes, or retainers in the shunt body to lock them together. If the retention features are constructed of hairs or sutures, they may be threaded or tied to the shunt. Alternatively, the retention features may be overmolded onto the shunt by an injection molding process. Alternatively, the entire shunt and retention features may be injection molded in a single step. Alternatively, the retention features may be formed onto the shunt with a post-processing step, such as flaring or thermoforming parts of the shunt.

[0141] The 105 shunt may be made of various materials, including, for example, polyimide, Nitinol, platinum, stainless steel, molybdenum, or any other suitable polymer, metal, metal alloy, or biocompatible ceramic material, or combinations thereof. Other materials of manufacture or materials with which the shunt may be coated or entirely fabricated include silicone, PTFE, ePTFE, differential fluoropolymer, FEP, FEP laminated onto ePTFE nodes, silver coatings (such as by a CVD process), gold, prolene/polyolefins, polypropylene, poly(methyl methacrylate) (PMMA), acrylic, poly(ethylene terephthalate) (PET), polyethylene (PE), PLLA, and parylene. The 105 shunt may be reinforced with polymer, Nitinol, or stainless steel braid or coil, or it may be a tube coextruded or laminated with one or more materials that provide acceptable flexibility and tangential strength for adequate lumen support and drainage through the lumen. The derivative can alternatively be manufactured from nylon (polyamide), PEEK, polysulfone, polyamideimides (PAI), polyether block amides (Pebax), polyurethanes, thermoplastic elastomers (Kraton, etc.) and liquid crystal polymers.

[0143] Any of the embodiments of shunt 105 described herein may be coated on its internal or external surface with one or more drugs or other materials, wherein the drug or material maintains the permeability of the lumen or stimulates tissue growth to aid with retention of the shunt within the eye or to prevent leakage around the shunt. The drug may also be used for the treatment of diseases. The shunt may also be coated on its internal or external surface with a therapeutic agent, such as a steroid, an antibiotic, an anti-inflammatory agent, an anticoagulant, an antiglaucoma agent, an antiproliferative agent, or any combination thereof. The drug or therapeutic agent may be applied in various ways as known in the art. The drug may also be incorporated into another polymer (nonabsorbable or bioabsorbable) that coats the shunt.

[0144] The shunt may also be coated or layered with a material that expands outward once the shunt has been placed in the eye. The expanded material fills any gaps left around the shunt. Such materials include, for example, hydrogels, foams, freeze-dried collagen, or any material that gels, swells, or otherwise expands upon contact with body fluids.

[0146] The shunt may also be covered or coated with a material (such as polyester, ePTFE (also known as GORE-TEX®), PTFE) that provides a surface to promote healing of the shunt in the surrounding tissue. To maintain a low profile, well-known sputtering techniques may be employed to coat the shunt. Such a low-profile coating would achieve the potential goal of preventing migration while also allowing for easy removal if desired.

[0148] In another embodiment shown in Figure 3B, which may be useful in some cases of glaucoma depending on the desired flow rate, the shunt 105 consists of an elongated wick member through which fluid can flow. The wick member may be formed from a single strand of material or from a plurality of interconnected strands, such as twisted, braided, or woven, through or along which fluid can flow. The wick member(s) do not necessarily include internal lumens, as flow through the wick member can occur by capillary action. In the case of a solid polymer wick, certain surface retainers may provide flow lumens between the core body member and the tissue of the suprachoroidal space.

[0150] The features of the shunts shown in Figures 3A and 3B can be combined as shown in Figure 3C. Thus, shunt 105 can include one or more wick members 315 in fluid communication with an internal (or external) lumen 305 of an elongated member. Aqueous humor flow occurs both through the internal lumen 305 and through or along the wick member 315.

[0152] In an exemplary embodiment, the branch has a length in the range of 2.54 mm to 19.05 mm (0.1" to 0.75") and an inside diameter for a flow path in the range of 0.0508 mm to 0.381 mm (0.002" to 0.015"). In one embodiment, the inner diameter is 0.3048 mm, 0.254 mm, or 0.2032 mm (0.012", 0.010", or 0.008"). A wick branch can have a diameter in the range of 0.0508 mm to 0.635 mm (0.002" to 0.025"). In the case of multiple branches being used, and for example each branch being 0.254 mm (0.01"), the fully implanted device can create a length of 5.08 mm to 25.4 mm (0.2" to 1.0"), although the length may be outside this range. One embodiment of the branch is 6.350 mm (0.250") long, has an inner diameter of 0.3048 mm (0.012 m") and an outer diameter of 0.015"). Another embodiment of the branch is 7.620 mm (0.300") long.

[0154] Shunt 105 has sufficient backbone strength to allow it to be inserted into the suprachoroidal space such that the distal tip of shunt 105 tunnels through the ocular tissue (such as the ciliary body) without structural collapse or degradation. Furthermore, the surface of the inner lumen 305 is sufficiently smooth relative to the insertion device (described in detail below) to allow shunt 105 to slide out of the insertion device during the insertion process. In one embodiment, the buckling strength is sufficient to allow the shunt to pass through the ocular tissue into the suprachoroidal space without any structural support from an additional structure such as an insertion device.

[0156] Shunt 105 can be configured to transition between a first reduced-size state and a second expanded-size state. For example, shunt 105 may be in a first state where it has a reduced radial size and/or overall length to facilitate fitting the shunt through a small portal during insertion. The shunt may then transition to a second state with an increased radial size and/or overall length. The shunt may also change its cross-sectional shape along its length.

[0158] The transition between the first and second states can be implemented in several ways. For example, the shunt can be made of a material such as Nitinol, which deforms in response to temperature variations or the release of a restrictive element. In this way, the shunt can be self-expanding or self-restraining at various locations along its length. In another embodiment, or in combination with a self-expanding shunt, the shunt can be expanded manually, such as by using an expansion balloon or by passing the shunt along a preformed device, such as a reverse-conical, tapered insertion trocar that increases in diameter. Additionally, the shunt can be placed inside a sheath during insertion, where the sheath maintains the shunt in the first, reduced-size state. At the time of insertion, the sheath can be removed to allow the shunt to expand in size.

[0160] Figure 5 shows an exemplary delivery system 510 that can be used to deliver shunt 105 to the eye according to the methods described in detail below. The delivery system 510 includes a handle component 515 that controls a shunt placement mechanism and an insertion component 520 that is attached so as to be withdrawn from shunt 105 for insertion of shunt 105 into the eye. The insertion component 520 includes an elongated applicator 525. In one embodiment, the applicator 525 has a tapered distal tip. The applicator 525 is sized to fit through the lumen of the lead 105 so that the lead 105 can be mounted onto the applicator 525. The applicator 525 may have a cross-sectional shape that complements the cross-sectional shape of the inner lumen of the lead 105 to facilitate mounting the lead onto the applicator 525. It should be noted that the applicator 525 does not have to employ a sharp distal tip. The applicator 525 may have an atraumatic or blunt distal tip so that it serves as a component for attaching to the lead or for blunt dissection, rather than as a cutting component.

[0162] The insertion component 520 also includes a lead advancement or deployment structure 530 positioned at a proximal end of the applicator 525. The advancement structure 530 can be an elongated tube positioned over the applicator 525. The delivery system 510 can be actuated to achieve a sliding motion relative to the advancement structure 530 and the applicator 525. For example, the advancement structure 520 can be moved in the distal direction (as represented by arrow 532), while the applicator 525 remains stationary to push or otherwise advance the lead 105 along the applicator 525 for lead 105 insertion into the eye. In an alternative embodiment, the applicator 525 is withdrawn distally toward the advancement structure 530 to withdraw the lead 105 from the applicator 525, as described below with reference to Figure 6B. In yet another embodiment, both the advance structure 530 and the applicator 525 move relative to each other to remove the shunt 105.

[0163] In one embodiment, the applicator 525 may be of sufficient length to receive a plurality of leads in a series arrangement end-to-end within the applicator 525. In this manner, multiple leads 105 may be loaded into the applicator 525 and inserted one at a time so that the leads collectively form an elongated lumen of sufficient length for adequate drainage. This allows for relatively short leads that can be used collectively in different eye sizes. Furthermore, multiple leads can be placed in multiple separate locations within an eye.

[0165] Applicator 525 or any portion of insertion component 520 may have an internal lumen extending its length to receive a guide wire that can be used during delivery of shunt 105. The internal lumen of insertion component 520 may also be used for fluid flow for the purpose of irrigating the eye. The internal lumen may be large enough to receive shunt 105 so that shunt 105 is mounted inside applicator 525, rather than over applicator 525, during insertion.

[0167] The handle component 515 of the delivery system 510 can be actuated to control the delivery of shunt 105. In this respect, the handle component 515 includes an applicator control 540 that can be actuated to extend the applicator 525 in the distal direction or retract it in the opposite (proximal) direction. The handle component 515 also includes an implant advancement actuator 535 that can be actuated to selectively move the advancement structure 530 along the applicator 525 in either a proximal or distal direction. In this way, the advancement structure 530 can be used to push the shunt 105 distally and out of the applicator 525 during insertion, or to hold the shunt 105 in a fixed location in the eye while the applicator 525 is being withdrawn.

[0169] The handle component 515 can be adapted so that it can be operated using only one hand. In addition, the delivery system 510 can include an actuating member that is separate from the handle 515 so that the operator can use a foot to actuate the delivery system 510. For example, a foot pedal or hydraulic system can be coupled or incorporated into the delivery system 510 to eliminate the need for the clinician's hand in the workplace. In this way, the clinician simply positions a cannula or delivery system by hand and uses the foot pedal to advance the shunt. PCT Publication No. WO06012421 describes an exemplary hydraulic assistance for an ablation catheter with a steerable tip.

[0171] In another embodiment, some of the functions of the 525 applicator and the 105 shunt are combined. That is, the distal tip of the 105 shunt may have a pointed or other shape (such as a beveled or blunt shape) at the distal end that facilitates penetration of the 105 shunt through the tissue. Illustrative methods for inserting the 105 shunt into the eye are described in detail below.

[0173] As mentioned, the 525 applicator may be equipped with one or more mechanisms that cause the expansion of lead 105. For example, the 525 applicator may include an expandable structure, such as an inflatable sleeve, mounted on a solid core of the 525 applicator. The inflatable sleeve is at least partially positioned within the internal lumen of lead 105 when lead 105 is mounted on the 525 applicator. During lead 105 administration, the inflatable sleeve expands when lead 105 is placed in the proper location in the eye to expand lead 105 and seat it in place. The sleeve then deflates or is otherwise reduced in size to allow the 525 applicator to be withdrawn from lead 105. Illustrative methods are described below.

[0175] The 525 applicator can be made of various materials, including, for example, stainless steel and Nitinol. The 525 applicator can be straight (as shown in Figure 5) or curved along all or a portion of its length (as shown in Figure 6A) to facilitate proper placement across the cornea. In this respect, the curvature of the 525 applicator can vary. For example, the 525 applicator can have a radius of curvature from 3 mm to 50 mm, and the curve can range from 0 degrees to 180 degrees. In one embodiment, the 525 applicator has a radius of curvature that corresponds to or complements the radius of curvature of a region of the eye, such as the suprachoroidal space. For example, the radius of curvature can be approximately 12 mm. In addition, the radius of curvature may vary along the length of the 525 applicator. There may also be means to vary the radius of curvature of portions of the 525 applicator during placement.

[0177] The applicator may also have a structure that enables or facilitates the use of the 525 applicator. For example, the distal tip of the 525 applicator may have a shape that facilitates blunt dissection of the target tissue, thus facilitating dissection in the suprachoroidal space. In this respect, the distal tip of the 525 applicator may be flat, spade-shaped, hoe-shaped, etc., for example.

[0179] Figure 6B shows another embodiment of the insertion device 510. The handle component 515 includes an actuator consisting of a knob 550 that can slide relative to the handle component 515. The knob 550 serves as an actuator that controls the sliding motion relative to the feed member 530 and the applicator 525. For example, with reference to Figures 6C and 6D, the feed member 530 can be fixed relative to the handle component 515. In a first state shown in Figure 6C, the applicator 525 extends outward relative to the feed member 530. Movement of the knob 550, for example in the proximal direction, causes the applicator 525 to slide proximally toward the feed member 530 as shown in Figure 6D.

[0181] This is described in more detail with reference to Figure 6E, which shows shunt 105 mounted on the distal applicator 525 of the advancement structure 530. When knob 550 is actuated, applicator 525 slides proximally into the advancement structure 530, as shown in Figure 6F. The proximal edge of shunt 105 rests against the distal edge of the advancement structure 530 to prevent shunt 105 from sliding proximally. In this way, applicator 525 is gradually withdrawn from shunt 105. As shown in Figure 6G, applicator 525 can be completely withdrawn into the advancement structure 530 so that shunt 105 is released from applicator 525.

[0183] Figure 6H shows an enlarged view of an exemplary distal region 537 of applicator 525. The distal region 537 of applicator 525 can be shaped to facilitate an approach to the suprachoroidal space. In this regard, as mentioned above, the distal region 537 can have a curved contour that complements the curved contour of the dissection plane, such as the suprachoroidal space.

[0185] At least a portion of the applicator 525 may be flexible. For example, the distal region 537 of the applicator 525 may be flexible so as to conform to the shape of the shunt 105 when the shunt 105 is mounted on the distal region 537. The distal region 537 may also conform to the shape of the advancement element 530 when the applicator 525 is withdrawn toward the advancement element 530.

[0187] The following describes various other embodiments of the 105 shunt. The reference number 105 is used to refer to all embodiments of the shunt, and it should be noted that the features of the various embodiments may be combined with other embodiments. As mentioned, the 105 shunt may include various types of structures and mechanisms to retain or otherwise anchor the position of the 105 shunt in the eye. For example, the 105 shunt may be equipped with a structure (such as a mesh structure or a spray-on coating) that facilitates endothelial tissue ingrowth around the shunt for permanent placement of the shunt.

[0189] Figure 7 shows an enlarged view of an end region, such as the distal end region, of the shunt 105. The end region includes retention structures consisting of one or more fenestrations, slits, or slots 705 located in the shunt 105. The slots 705 are shown arranged in series along the end region of the shunt 105, although it should be noted that the spatial configuration, size, and angle of the slots 705 may vary. The shunt 105 shown in Figure 7 has a distal wall 710 that at least partially encloses the distal end of the internal lumen. The distal wall 710 may have a slot 705 for fluid flow into and out of the lumen. Alternatively, the distal wall 710 may be absent, leaving an opening for fluid flow. The slots can function to allow fluid flow in addition to the central lumen of shunt 105.

[0191] The 705 grooves form edges that interact with the surrounding tissue to prevent the 105 shunt from detaching once implanted in the eye. The 705 grooves form openings that communicate with the internal lumen of the 105 shunt for the entry and exit of aqueous humor relative to the lumen. The proximal end of the shunt may also be equipped with an arrangement of 705 grooves.

[0193] Figure 8 shows another embodiment of shunt 105 in which a plurality of holes are located in the side walls of shunt 105 and spaced along its length. The holes facilitate fluid flow into and out of the internal lumen of shunt 105. Shunt 105 can be configured so that it initially has no holes. After shunt 105 is placed in the eye, one or more holes can be formed in the shunt, such as by applying a laser (e.g., a YAG laser) to shunt 105 or by using other means to form the holes.

[0195] Each of the orifices can communicate with a separate flow pathway that extends through shunt 105. That is, shunt 105 can include a plurality of internal lumens where each internal lumen communicates with one or more of the orifices in the side wall of the shunt.

[0197] Figure 9A shows another embodiment of the branch 105 that includes an elongated portion 905 of fixed size and one or more expansion members 910. The elongated portion 905 includes an internal lumen and one or more openings for fluid inlet and outlet relative to the lumen. The expansion members 910 are configured to transition between a first reduced-size state and a second expanded or enlarged-size state. The structure of the expansion members 910 may vary. In the illustrated embodiment, each expansion member 910 is formed by a plurality of axially extending rods or prongs connected at opposite ends. The rods can deform outward along their length to expand the radial size of the expansion member 910. The expansion of the expansion members 910 can be implemented in various ways, such as by using an expansion balloon or by fabricating the expansion members from a material like Nitinol that deforms or expands in response to temperature variations, or a shrinkable sleeve 915 that allows the expansion of a shunt formed from a resilient material. The expansion members can also be oriented outward so that they expand on their own when unrestrained.

[0199] As shown in Figure 9B, one embodiment of the 910 expansion members consists of prongs that extend or fan outward. The prongs are configured to maintain open tissue in the suprachoroidal space. One or both of the 910 expansion members may include separate prongs. For example, expansion member 910a may be configured as in Figure 9A, while expansion member 910b may be configured as in Figure 9B (or vice versa). In addition, the shunt may include three or more expansion members.

[0201] The expansion members 910 can be biased toward the expanded state such that, when unopposed, the expansion members 910 automatically move into the expanded state. In this case, each of the expansion members 910 can be positioned within a sleeve 915 during insertion, wherein the sleeve 915 maintains the expansion members 910 in the reduced-size state. The sleeve 915 is removed from the expansion members to allow the expansion members 910 to self-expand. The sleeve 915 can have strong tangential and tensile strength to maintain the expansion members 910 in an unexpanded state until the shunt 105 is in a suitable location in the eye. In one embodiment, the sleeve 915 is made of poly(ethylene terephthalate) (PET).

[0203] The embodiment of Figure 9A includes a first expansion member 910a at a distal end of branch 105 and a second expansion member 910b at a proximal end of branch 105. It should be noted that the number and location of the expansion members 910 in the branch may vary. For example, branch 105 may include only a single expansion member 910 at the proximal or distal end, or it could include one or more expansion members interspersed along the length of portion 905. The expansion members may be configured in other geometries, for example, lattice, coiled, or combinations thereof.

[0205] Figure 10 shows another embodiment of shunt 105 that includes a retention member 1005 located at the proximal end of shunt 105. The retention member 1005 is enlarged relative to the rest of the shunt and is shaped to prevent the shunt from moving further into the suprachoroidal space after it has been correctly positioned. The enlarged shape of the retention member 1005 can be lodged against tissue to prevent movement of shunt 105 into or out of a predetermined location, such as the suprachoroidal space. The retention member 1005 in Figure 10 is funnel- or cone-shaped, although the retention member 1005 can have various shapes and sizes configured to prevent the shunt from moving further into the suprachoroidal space. For example, the retention member 1005 may be plate- or flange-shaped.

[0207] Lead 105 in Figure 10 is tapered along its length, such that the diameter of lead 105 gradually decreases as it moves distally. The distal direction is represented by arrow 532 in Figure 10. The tapered configuration may facilitate smooth insertion into the eye. The taper may exist along the entire length of the lead or only along one or more regions, such as a distal region. In addition, the lead may have a bulbous section approximately at its midpoint to provide an additional means of anchoring. The bulbous section may be an expandable member or a balloon element. Leads with bulbous sections are described in detail below.

[0209] As mentioned, shunt 105 includes an internal lumen. The lumen may have a uniform diameter along the length of the shunt or it may vary in diameter. In this regard, the diameter of the internal lumen can be decreased to achieve a desired fluid flow rate through the shunt. Thus, the lumen diameter can be varied to regulate fluid flow through the shunt. Flow regulation can also be achieved by varying the size, number, and/or position of the orifices 1010 in the distal region of shunt 105, where the orifices 1010 communicate with the internal lumen. The orifices 1010 can thus have shapes, sizes, and numbers selected to achieve a desired intraocular pressure as a result of aqueous humor flow through the shunt. In addition, the use of multiple orifices allows fluid to flow through bypass 105 even when one of the orifices 1010 is blocked.

[0211] During shunt administration, the 1010 holes can be positioned to align with predetermined anatomical structures of the eye. For example, one or more 1010 holes can be aligned with the suprachoroidal space to allow aqueous humor to flow into the suprachoroidal space, while another set of 1010 holes aligns with structures proximal to the suprachoroidal space, such as structures in the ciliary body or anterior chamber of the eye. The shunt may have visual markers along its length to assist the user in positioning the desired portion of the shunt within the anterior chamber. In addition, the shunt and delivery system may employ alignment marks, tabs, grooves, or other features that allow the user to identify the alignment of the shunt relative to the insertion device.

[0213] Figure 11 shows an embodiment of lead 105 that includes one or more grooves 1105 positioned around the circumference of the lead. The grooves 1105 provide variations in the lead structure that allow the lead to flex during insertion to enable proper placement of lead 105 from the anterior chamber of the eye to the suprachoroidal space. Lead 105 may also be fabricated from a flexible material with or without grooves 1105. Lead 105 may have other features that provide flexibility to the lead. For example, the lead may be scored or laser-cut to provide flexibility at various locations along its length. The scores may be located at various positions along the length of lead 105 to provide localized variation in lead flexibility. For example, a distal region may have a plurality of stripes to provide greater flexibility, while a proximal region includes a reduced number of stripes that provide less flexibility than the distal region.

[0215] Figure 12 shows an embodiment of shunt 105 that includes a distal coil member 1205. The coiled configuration of the coil member 1205 provides greater flexibility to the distal region of shunt 105 to facilitate traction in the suprachoroidal space. In addition, the coil member 1205 can facilitate fluid flow from the internal lumen into the suprachoroidal space. The coil member 1205 can allow a screw-in motion to advance and/or secure shunt 105 in the eye. The distal tip of shunt 105 can have an atraumatic shape, such as a ball shape (as shown in Figure 12). The distal tip can alternatively have a pointed tip and a barbed shape that retains the shunt in the eye, as shown in Figure 13. Any of the features described herein as being present on the distal tip could also be located on the proximal tip of the shunt.

[0217] Illustrative insertion and implantation methods

[0219] An exemplary method of shunt administration and implantation in the eye is described below. In general, the shunt is implanted using the delivery system by accessing the scleral spur to create a low-profile dissection in the tissue plane between the choroid and sclera. The shunt is then fixed in the eye to provide communication between the anterior chamber and the suprachoroidal space.

[0221] Figure 14 shows a cross-sectional view of the eye. A viewing lens 1405 (such as a gonioscopy lens schematically represented in Figure 14) is positioned adjacent to the cornea. The viewing lens 1405 enables visualization of internal regions of the eye, such as the scleral spur and scleral junction, from a location in front of the eye. The viewing lens 1405 may optionally include one or more guide channels 1410 that are sized to receive the insertion portion 520 of the insertion device 510. It should be noted that the locations and orientations of the guide channels 1410 in Figure 14 are merely illustrative and that the actual locations and orientations may vary depending on the angle and location where the lead 105 is to be inserted. An operator may use the viewing lens 1405 during lead insertion into the eye. The 1405 viewing lens may be shaped or cut to allow the surgeon to use it in a way that does not cover or obstruct access to the corneal incision. Additionally, the viewing lens may act as a guide through which a 510 insertion device can be positioned to predetermine the device's path as it is inserted through the cornea.

[0223] An endoscope may also be used during administration to aid in visualization. For example, a 21- to 25-gauge endoscope may be attached to the shunt during insertion, either by mounting the endoscope along the side of the shunt or coaxially within it. Ultrasonic guidance may also be used with high-resolution biomicroscopy, OCT, and similar techniques. Alternatively, a small endoscope may be inserted through another limbal incision into the eye to image the tissue during the procedure.

[0225] As an initial step, one or more 105 leads are mounted on the insertion device 510 for delivery to the eye. As mentioned, at least one 105 lead can be mounted on the applicator 525 or mounted inside the applicator 525. The eye can be viewed through the viewing lens 1405 or another viewing device as described above to determine the location where the 105 lead should be inserted. At least one objective is to insert the 105 lead into the eye so that it is positioned with the internal lumen of the shunt to provide a fluid pathway between the anterior chamber and the suprachoroidal space. If a tube shunt with an internal lumen is used, then the internal lumen is positioned so that at least one lumen inlet communicates with the anterior chamber and at least one outlet communicates with the suprachoroidal space. If a wick shunt is used, then the wick member can communicate with both the anterior chamber and the suprachoroidal space. As mentioned, the tube member and the wick member can be combined. In such a case, the internal lumen can open into the anterior chamber and open at least partially into the suprachoroidal space, while the wick member extends further into the suprachoroidal space.

[0227] With reference to Figure 15A, the insertion device 510 is positioned so that the distal tip of the applicator 525 or the shunt 105 itself can penetrate through the cornea. In this respect, an incision is made through the eye, as within the limbus of the cornea. In one embodiment, the incision is made very close to the limbus, for example, at the level of the limbus or 2 mm from the limbus in the transparent cornea. The applicator 525 can be used to make the incision, or a separate cutting device can be used. For example, a knife-tipped device or a diamond knife can be used to initially enter the cornea. A second device with a spatula tip can then be advanced over the knife tip, where the spatula plane is positioned to coincide with the dissection plane. In this way, the spatula-shaped tip can be inserted into the suprachoroidal space with minimal trauma to the eye tissue.

[0229] The incision is large enough to allow passage of the shunt through it. In this respect, the incision may be sized to allow passage of the shunt alone without any additional devices, or it may be sized to allow passage of the shunt along with additional devices, such as an insertion device or an imaging device. In one embodiment, the incision is approximately 1 mm in size. In another embodiment, the incision is no larger than approximately 2.85 mm. In yet another embodiment, the incision is no larger than approximately 2.85 mm and larger than approximately 1.5 mm. An incision up to 2.85 mm has been observed to be self-sealing. For clarity, the drawing is not to scale, and the viewing lens 1405 is not shown in Figure 15A, although the applicator can be guided through one or more guide channels in the viewing lens. The 525 applicator can be approached to the suprachoroidal space from the same side of the anterior chamber as the deployment site, so it is not necessary to advance the applicator through the iris. Alternatively, the applicator can be approached to the site from the other side of the anterior chamber, so that it advances through the iris and/or the anterior chamber. The 525 applicator can be approached to the eye and the suprachoroidal space via a variety of approaches. Several approaches for approaching the eye and deploying the shunt are described in detail below.

[0231] After insertion through the incision, the 525 applicator advances through the cornea and anterior chamber. The applicator advances along a pathway that allows insertion of the shunt from the anterior chamber into the suprachoroidal space. In one embodiment, the applicator is advanced along a pathway directed toward the scleral spur, such that the applicator crosses the scleral spur on its way to the suprachoroidal space. The 525 applicator can be preformed, oriented, articulated, or shaped to facilitate its approach to the suprachoroidal space along a suitable angle or pathway.

[0233] As mentioned, a guide wire can also be used to guide the applicator or shunt over the guide wire to the proper location in the eye. The guide wire can be looped at one distal end to assist in performing a suprachoroidal dissection. Once the shunt is correctly positioned, the loop can be released. If it is necessary to remove the shunt before releasing the loop, the guide wire loop can act as a retrieval mechanism. The loop can be larger than the distal lumen opening of the shunt so that when the guide wire is pulled back, the loop pulls the shunt along with it.

[0235] The guidewire can be left in place even after the applicator is removed. This allows the user to repeatedly access the site via the guidewire without having to reposition the site in the eye. A cannula can be used to create an access pathway to the insertion site. The insertion tool can then be inserted through the cannula. The cannula can be held in place with the viewing lens, and the end of the insertion device can be articulated or steerable so that multiple leads can be placed from one access site. For example, an infusion cannula from the Netherlands Ophthalmological Research Centre (DORC) can be used, particularly models that allow continuous infusion and aspiration to maintain a sufficient working area within the anterior chamber.

[0236] As discussed, the distal tip of the 525 applicator can be sharpened and can also be tapered to facilitate smooth penetration through the cornea. The distal tip of the 105 shunt can also be sharpened. In addition, the tip of the applicator device can be connected to an ES power source, allowing energy to be delivered to the tip of the applicator body to help create the initial corneal stick and further facilitate entry into the suprachoroidal space through the scleral spur. In this embodiment shown schematically in Figure 15B, only the most distal tip is exposed for applying energy to the tissue, and the remaining shaft of the applicator is insulated, for example, with a sleeve made of insulating material. Power insertion leads are connected to the shaft of the applicator (such as through the handle) to energize the tip portion, and these leads are also connected to an ES power insertion source and any required grounding pad. The energy that can be delivered to facilitate the procedure may be RF energy, laser energy, resistive thermal energy, or ultrasonic energy. A medical-grade energy delivery system, such as those produced by Stellertech Research (Mountain View, California), for example, can be used to deliver RF energy to the applicator tip. Figure 16 shows a magnified view of the anterior region of the eye, including the anterior chamber (AC), cornea (C), iris (I), sclera (S), and choroid (CH). The suprachoroidal space is located at the junction between the sclera and choroid. Shunt 105, mounted on applicator 525, is shown approaching the suprachoroidal space from the anterior chamber. The distal tip of applicator 525 is moved along a track so that it is positioned on the scleral spur, with the curve of applicator 525 directed toward the suprachoroidal space. In this regard, the 525 applicator and/or the 105 shunt may have a radius of curvature that matches the radius of curvature of the suprachoroidal space. The surgeon can rotate or reposition the handle of the insertion device to obtain a suitable approach path for the distal tip of the applicator, as described in more detail below.

[0238] The scleral spur is an anatomical landmark on the angle wall of the eye. The scleral spur is above the level of the iris but below the level of the trabecular meshwork. In some eyes, the scleral spur may be masked by the lower band of the pigmented trabecular meshwork and lie directly behind it. With the 525 applicator positioned for approximation, the applicator is then advanced further into the eye so that the distal tip of the applicator and/or shunt penetrates the scleral spur. Penetration through the scleral spur can be achieved in various ways. In one embodiment, a sharp distal tip of the applicator or shunt pierces, penetrates, dissects, traverses, or otherwise passes through the scleral spur into the suprachoroidal space. Scleral spur crossing, or crossing of any other tissue, can be assisted, for example, by applying energy to the scleral spur or tissue through the distal tip of the 525 applicator. The means of applying energy can vary and may include mechanical energy, such as creating a frictional force to generate heat in the scleral spur. Other types of energy, such as RF laser, electrical, etc., can also be used.

[0240] The 525 applicator advances continuously into the eye, through the trabecular meshwork and ciliary body, until the distal tip is positioned in or near the suprachoroidal space, such that a first portion of the 105 shunt is positioned within the suprachoroidal space and a second portion is positioned within the anterior chamber. In one embodiment, at least 1 mm to 2 mm of the shunt (along its length) remains in the anterior chamber. Figure 17 shows the distal tip of the 525 applicator positioned within the suprachoroidal space (SS). For clarity, Figure 17 does not show the shunt mounted on the applicator, although the 525 shunt is mounted on the applicator during insertion. As the 525 applicator advances through the tissue, the distal tip causes the sclera to detach or otherwise separate from the choroid to expose the suprachoroidal space.

[0242] One method of approximation is to advance the 525 applicator through the ciliary body as it approaches the suprachoroidal space. The sclera is structurally tougher than the ciliary body. As the distal tip of the 525 applicator passes through the ciliary body and reaches the scleral tissue, the scleral tissue provides increased resistance to the passage of the 525 applicator. Thus, the surgeon will detect an increase in resistance as the distal tip of the applicator passes through the ciliary body and reaches the sclera. This can serve as an indication that the distal tip of the applicator has reached the suprachoroidal space. In this regard, the distal region of the 525 applicator or shunt may have a shape, such as a scoop or a blunt end, configured to facilitate the creation of a dissection plane between the choroid and sclera and the positioning of the distal applicator in the suprachoroidal space. The thickness of this dissection plane is approximately the same as the size of the device being placed. The distal region may be flexible or loop-shaped to allow preferential movement into the space between the sclera and choroid.

[0244] As mentioned, the insertion device 510 and/or the lead 105 may be equipped with navigation aids, such as radiopaque markers, or means to enable ultrasonic visualization that assist in the proper positioning of the applicator and lead in the eye. Once the applicator 525 has been correctly positioned, the lead 105 is advanced out of the applicator 525, such as by actuating the implant advancement actuator 535 to move the advancement structure 530 (Figure 5) so that the lead 105 is pushed out of the applicator into proper placement in the eye.

[0246] Shunt 105 can be deployed out of the applicator in several ways. For example, as explained above, the shunt can be pushed out of the applicator by moving the advancement structure 530 (shown in Figures 5–6G) distally. In an alternative method, the advancement structure 530 remains stationary, and the applicator 525 is withdrawn proximally, as described above with reference to Figures 6E–6G. This method can be advantageous because the shunt remains stationary during the removal of the applicator 525 instead of moving. In this way, the shunt can be correctly positioned while still in the applicator 525. In another method, the applicator is advanced distally into the suprachoroidal space while the shunt remains stationary against the advancement structure 530. The advancement structure is then moved distally to push the shunt along the applicator. Next, the applicator is withdrawn toward the advancement structure to detach the applicator shunt.

[0248] The shunt may include structural features that aid in proper shunt placement, such as ensuring that the 105 shunt does not advance further into the eye than necessary. For example, the 105 shunt may include a structure, such as the proximal retention member 1005 (shown in Figure 10), that rests on the scleral spur or other tissue structure to prevent further movement of the shunt within the eye. Figure 18 shows a 105 shunt equipped with a skirt 1805, and Figure 19 shows a shunt equipped with a spiked skirt 1810. As shown in Figure 20, the skirt 1810 or 1805 rests on and anchors to the ciliary body to prevent the 105 shunt from advancing further into the eye. These features may also serve to prevent fluid leakage around the outside of the shunt. Previous efforts to increase anterior chamber drainage by surgically creating a pathway between the anterior chamber and the suprachoroidal space, known as cyclodialysis procedures, often resulted in excessive drainage and low pressure ("hypotonia") in the anterior chamber. The concern about excessive flow and the resulting hypotony may be a major reason why previous efforts have focused on placing shunts through a scleral incision, so that the sclera surrounds at least a portion of the shunt to prevent flow around it. Therefore, these methods of preventing flow around the outside of the shunt may prove essential to enabling the placement of a shunt directly from the anterior chamber into the suprachoroidal space without the risk of hypotony.

[0250] Figure 21 shows the 105 shunt implanted in the eye to provide a fluid pathway between the anterior chamber (AC) and the suprachoroidal space (SS). The 105 shunt was implanted by "tunneling" the shunt into the suprachoroidal space. That is, as the shunt is advanced into the suprachoroidal space, the distal tip of the applicator and/or the shunt penetrates the tissue and forms a tunnel through the ocular tissue, initially the ciliary body. This differs from a procedure where the shunt is brought down into the eye through a scleral flap that is cut and folded back to access the implant site. In this procedure, the implanted shunt is placed within a cavity formed by the folded-back flap. However, in the procedure shown in Figure 21, the 105 shunt is substantially enclosed or surrounded by ocular tissue in the region between the anterior chamber and the suprachoroidal space. It also differs from the procedure known as cyclodialysis, which in some cases completely detaches the ciliary body from the scleral spur to relieve pressure in the anterior chamber, because essentially a puncture is made and the shunt device that is placed is left in the position of the puncture.

[0251] Although Figure 21 shows only a single shunt 105, it should be noted that multiple shunts can be implanted in the eye. Shunts can be implanted end-to-end to form a single, elongated fluid pathway, or a plurality of shunts can be placed side-by-side or spaced around the circumference of the anterior chamber to form multiple fluid pathways. Furthermore, a single shunt can be implanted in an initial procedure, and additional shunts can be implanted in one or more subsequent procedures as needed to establish or maintain optimal anterior chamber pressure.

[0253] If multiple shunts are used, it is not necessary for all shunts (or all openings in a shunt) to be patent initially. This allows drainage of the aqueous humor to be initiated in a controlled manner by selectively opening additional shunts over a period of time. Over time, additional shunts can be activated (i.e., opened), such as by inserting a stylet or other needle-like device, as during an office visit. Shunts can also be opened or reopened (if a shunt becomes blocked after implantation) in various ways, such as by a photochemical, laser, radiofrequency, ultrasound, or thermal procedure, or combinations thereof. For example, the shunt may have a single or multiple holes along its proximal or distal end, one or more of which are initially covered by a second tube or other material. Applying light or other energy to the tube could cause the holes to open or could cause the tube to shrink lengthwise, exposing additional openings to increase flow.

[0255] Furthermore, the outer diameter of the shunt or the diameter of the inner lumen can be varied by shortening or widening the shunt through thermal, light, or photochemical activation. For example, the shunt may initially be relatively long and thin. Applying energy or other activation to the shunt could cause it to shorten and/or widen in diameter, increasing its flow rate.

[0257] The dissection created by the shunt may cause a leak between the anterior chamber and the suprachoroidal space. In such a case, the leak can be filled or otherwise sealed with a material (such as foam or adhesive) or a structure (such as a gasket) that prevents leakage.

[0259] With reference still to Figure 21, a spacer structure 2110 may optionally be located at the proximal end of lead 105. The spacer structure 2110 is a structure that extends outward from lead 105 to prevent blocking the proximal end of lead 105. With further reference to Figure 21, the structure 2110 may also facilitate grasping the lead should it be necessary to remove it.

[0260] In another embodiment, lead 105 is not positioned on applicator 525 as the applicator advances toward the eye. In such a case, the handle component 515 of the insertion instrument can be separated from the proximal end of the applicator after the applicator has been correctly positioned on the eye. Lead 105 is then screwed onto the applicator, from the proximal end to the distal end, toward the insertion site.

[0262] In one implementation, a passage is formed in the eye before advancing the applicator through it. The applicator is then advanced through the previously formed passage instead of using the applicator to tunnel through the eye. The passage can be formed in various ways, such as by using a power source or phacoemulsification equipment.

[0264] Additional realizations of the shunt and management system

[0266] Further embodiments of the shunt 105 are described below. Figure 22 shows a shunt 105 that includes an elongated core member 2205 having one or more external fluid flow features, such as flow channels 2210, located on its outer surface. The flow channel(s) 2210 define at least one passage for aqueous humor flow along the length of the shunt 105. The configuration of the flow channel(s) 2210 may vary. In the embodiment of Figure 22, a single flow channel 2210 having a helical or spiral configuration is located on the outer surface of the core member 2205. The core 2205 may also include multiple spiral flow channels. Figure 23 shows another embodiment, wherein a plurality of straight or substantially straight flow channels are located on the outer surface of the core member 2205. The branch 105 may also include a single straight flow channel or may include a combination of straight flow channels and flow channels of various curvilinear configurations.

[0268] The 2205 core can be a solid piece of material without an internal lumen. A solid 2205 core can form a strong structure and create a reliable flow pathway with a reduced risk of structural collapse or tissue growth in the lumen. Alternatively, external flow channels can be combined with an internal lumen that extends through the 2205 core. If the 2205 core is solid without an internal lumen, it can be inserted into the eye through an insertion lumen of an insertion device, such as an applicator. If the 2205 core includes an internal lumen, it can be inserted into the eye mounted on an insertion device, such as an elongated applicator.

[0270] Core 2205 can be manufactured in several ways. For example, Core 2205 can be molded or extruded, such as from a biocompatible material or any of the materials described herein. Core 2205 can also be formed from a combination of different materials or can be coextruded.

[0272] Figure 24 shows a shunt 105 that includes an elongated outer member 2405, such as a stent, mounted on a plug member 2410. When this embodiment of the shunt 105 is implanted between the anterior chamber and the suprachoroidal space, the plug member 2410 degrades over time, while the outer member 2405 does not. The outer member 2405 remains in the eye to maintain a patent passage between the anterior chamber and the suprachoroidal space. The outer member 2405 may be solid (such as an elongated tube) or it may be a mesh. The outer member 2405 may be integrally formed with the plug member 2410 or it may be incorporated to varying degrees within the plug member to control the rate of degradation.

[0274] The degradation of the 2410 plug can be configured in several ways. For example, the plug degradation rate can be based on intraocular pressure, so that the degradation rate increases as intraocular pressure increases. Therefore, higher intraocular pressure results in a higher plug degradation rate than lower intraocular pressure. In this way, the plug degradation rate can decrease as intraocular pressure approaches a predetermined value.

[0276] An exemplary way to implement such a feature is to include an internal lumen 2510 in the plug 2410, as shown in Figure 25A. In an initial state, the lumen 2510 has a reduced diameter, such that a low level of aqueous humor flows through it. This initial state may correspond to the plug being exposed to an initially high intraocular pressure. The high intraocular pressure causes the plug 2410 to degrade, increasing the size of the lumen. As the lumen size increases (as shown in Figure 25B), the level of aqueous humor flow through the lumen also increases, resulting in a reduction of intraocular pressure and a reduction in the rate of plug degradation.

[0278] In an alternative embodiment of the device shown in Figure 24, the 2405 stent does not include an internal member. In this way, an endoprosthesis 2405 is implanted in the eye, maintaining an opening between the suprachoroidal space and the anterior chamber. The 2405 endoprosthesis may be a self-expanding endoprosthesis or a balloon-expandable endoprosthesis that expands after placement within the eye. The 2405 stent may be, for example, a braided or laser stent made of stainless steel or Nitinol.

[0280] The shunt may also be made of a material that is absorbed into the ocular tissue after placement in the eye. Once absorbed, a space remains where the shunt was previously located. In this respect, the shunt may be made of a complex carbohydrate or a non-inflammatory collagen. In another embodiment, the shunt is covered or filled with a material that is absorbed into the eye over time to prevent hypotony or to prevent the formation of a clot within the tube.

[0282] In the case of biodegradable or bioabsorbable devices, a variety of materials can be used, such as biodegradable polymers including: hydroxyaliphatic carboxylic acids, either homo- or copolymers, such as polylactic acid, polyglycolic acid, polylactic glycolic acid; polysaccharides such as cellulose or cellulose derivatives such as ethylcellulose, crosslinked or non-crosslinked sodium carboxymethylcellulose, sodium carboxymethylcellulose starch, cellulose ethers, cellulose esters such as cellulose acetate, cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate and calcium alginate, polypropylene, polybutyrates, polycarbonate, acrylate polymers such as polymethacrylates, polyanhydrides, polyvalerates, polycaprolactones such as poly-Y-caprolactone, polydimethylsiloxane, polyamides, polyvinylpyrrolidone, polyvinyl alcohol phthalate, waxes such as paraffin wax and white beeswax, natural oils, shellac, zein or a mixture thereof, as listed in Wong's United States Patent 6,331,313.

[0284] Figure 26 shows another embodiment of the bypass, which is formed by a sponge-like flow member 2610 made of a porous material, such as polyester. The porous nature of the flow member 2610 creates one or more fluid pathways for the flow of aqueous humor through the flow member. The flow member 2610 may be made of a material that can be perforated along its length by a wire or other structure. The perforation forms an internal lumen 2710 (Figure 27) through which the aqueous humor can flow. The internal lumen 2710 can be formed in situations where it is desired to increase the flow of aqueous humor through the flow member.

[0286] Figure 28 shows another embodiment of shunt 105 that includes a pair of anchoring members 3305 located at opposite ends of the shunt. The anchoring members 3305 are sized and shaped to suit their attachment to ocular tissue to retain shunt 105 in a fixed or substantially fixed position within the eye. Shunt 3305 includes an elongated central region on which one or more prongs or teeth 3310 are arranged, adapted to anchor with the eye. The anchoring members 3305 and teeth 3310 extend outward from shunt 105 to define a space 3315 arranged along at least one side of shunt 105 when shunt 105 is positioned in the eye. The teeth may be oriented to extend at least partially into the trabecular meshwork so as to form flow pathways to Schlemm's canal. The 3310 teeth can be made of various materials, including silver, or they can be silver-coated. Silver is a material that inhibits the growth of surrounding tissue, thus preserving space around the shunt.

[0288] As discussed earlier with reference to Figure 7, a distal or proximal end of the 105 shunt may be equipped with retention structures. Figure 29 shows a distal and/or proximal end region of the 105 shunt that includes cuts that generally extend along the longitudinal direction of the shunt. The orientation of the cuts may vary. For example, the cuts may extend longitudinally, defining a plurality of longitudinally extending teeth that may interact with the ocular tissue to resist migration of the 105 shunt. The cuts may also be oriented transversely to the longitudinal axis of the shunt. The end region may flare outward to provide additional resistance to migration.

[0290] In another embodiment, shown in Figure 30, one or more cuffs 3405 are positioned on the outer surface of the lead 105. The cuffs 3405 can be inserted at various locations along the length of the lead 105. In the embodiment of Figure 30, a first cuff 3405 is located in a distal region of the lead 105, and a second cuff 3405 is located in a proximal region of the lead 105. More than two cuffs can be placed on the lead. The cuffs 3405 have an inner diameter that allows them to be securely mounted on the lead. The outer diameter of the cuff is larger than the outer diameter of the lead, so that the cuffs form a raised surface on the lead. 3405 sleeves can be annular, meaning they have an internal lumen that fits completely around the circumference of the shunt. Alternatively, 3405 sleeves are non-annular strips of material that are placed over the shunt so that they cover only a portion of its circumference.

[0292] As an alternative or in addition to sleeves placed over the branch, the outer surface of the branch may include grooves machined or molded into the outer surface. The grooves may be a series of annular grooves or a single corkscrew-shaped groove extending the length of the branch. The grooves serve to form alternating raised and recessed surfaces on the branch. The branch may also include holes or markings on the outer surface.

[0294] 3405 cuffs may have a smooth outer surface, a wavy outer surface, or may include one or more cuts that can be oriented at various angles with respect to the longitudinal axis of the shunt 105. The cuts form teeth on the 3405 cuffs to resist shunt migration. The cut teeth may be angled outward so that they flare outward and engage with the adjacent tissue to prevent movement in a proximal or distal direction.

[0296] Either of the cuffs can also act as a marker to show the clinician the appropriate length of shunt to be inserted into the eye. Alternatively, one or more printed markers can be formed on the outer wall of the shunt or on the insertion device. The markers can be BaSO4 markers embedded in the wall of the shunt material, wherein the markers are made of an extruded polymer composite with this radiopaque substance in the region of the desired radiopacity. In addition, the markers can be laser-printed or etched onto the shunt device to show the amount of shunt deployed in the suprachoroidal space or the amount by which the shunt device should be allowed to protrude into the anterior chamber. The cuffs can be made of various materials. In one embodiment, at least one of the cuffs is made of an antimicrobial silver material.

[0298] Figure 31 shows another embodiment of the 105 shunt with 3605 cuffs arranged at the proximal and distal ends of the shunt. The 3605 cuffs have cuts that form arcs. The cuts can be straight or curved. When the cuts are located in the 3605 cuffs rather than in the body of the shunt itself, the cuts will not interfere with fluid flow through the shunt lumen. There is a risk that if the cuts are made in the shunt itself, tissue growth will occur into the cuts. This growth can interfere with fluid flow through the internal lumen of the shunt. Advantageously, the cuffs allow the use of cuts that do not interfere with the internal lumen of the shunt. The cuts in the cuffs create retention mechanisms at both ends of the shunt. The cuts are angled toward each other to prevent micromovement of the shunt. As a force acts on the shunt to force the shunt into the suprachoroidal space or into the anterior chamber, the cuts begin to extend axially from the longitudinal axis of the internal lumen, causing a restriction of shunt movement in any direction.

[0300] Figure 32 shows yet another embodiment of shunt 105. In this embodiment, a retaining structure, such as a coil 3705, is located on the outside of shunt 105. The coil 3705 may be formed by a wire wound around the outer surface of the shunt. The coil 3705 functions to retain shunt 105 within the eye. In some embodiments, the coil 3705 may also be sized and shaped so as to form a conduit or flowway that directs fluid to flow along the outside of the shunt. The retaining structure need not be coiled but may have various shapes and sizes adapted to hold the shunt in place. For example, the retaining structure may be a straight wire extending the length of the shunt and raised above the outer surface of the shunt. The wire may have various dimensions. In one embodiment, the wire has a diameter of 0.0127 mm (0.0005 inches).

[0302] It may be desirable to place one or more structures on the lead that can be grasped, for example, to reposition the lead or remove it from the eye. Some embodiments of the lead that include the removal or repositioning of structures are described below. The removal or repositioning structure can be any structure on the lead that can be grasped to move or remove the lead. For example, the removal structure could be an enlarged region, a raised region, or a region of reduced diameter that provides a location that can be grasped by a removal tool. The retention elements described above can also serve as a grasping element for removing or moving the lead.

[0304] Figure 33A shows an embodiment of shunt 105 that includes a gripping loop 3805 at the proximal end of the shunt. The gripping loop 3805 is shaped so that it can be grasped with a withdrawal or repositioning tool. The gripping loop 3805 can be connected to a coil member 3810 that extends wholly or partially along the length of shunt 105 so that when the gripping loop is pulled, the shunt undergoes radial reduction in size, as shown in Figure 33B. The shunt may also include external threaded structures that allow the shunt to be screwed into the suprachoroidal space by rotating the shunt in one direction and then unscrewed by rotating it in the opposite direction. The threads can grip the surrounding tissue to provide countertraction when the gripping loop 3805 is pulled. Shunt 105 can also be formed by a braided shaft with a distal gripping loop 3805, as shown in Figure 34.

[0306] Figure 35 shows another embodiment of an elongated device 4002 with a loop 4005 located at a proximal end. The device 4002 can be placed within a shunt lumen so that the loop 4005 is compressed within the lumen. In use, the device 4002 is partially withdrawn from the lumen so that the loop 4005 expands to form a loop that can be grasped with a withdrawal or repositioning tool.

[0308] In another embodiment, shown in Figure 36, the shunt 105 includes a distal region 4105 that is flat and thin, giving it a spatula-like shape. The flat, thin configuration of the shunt is adapted to facilitate penetration into the eye and to facilitate detachment of the choroid from the sclera and positioning of the distal applicator region in the suprachoroidal space. The shunt includes an internal lumen for the passage of a guide wire or through which viscoelastic fluid or substance(s) can be passed to facilitate dissection or visualization. Additionally, an optical fiber can also be passed through the lumen to facilitate direct visualization of the treatment region as desired during shunt placement or repositioning.

[0310] As mentioned, the shunt 105 may have a shape or configuration that minimizes the risk of trauma to the eye during placement or during micromovement of the shunt after it has been administered. For example, any region of the shunt may have an atraumatic shape or may be made of or coated with a soft material. In one embodiment, shown in Figure 37, an atraumatic tip 4205 is located in the proximal region of the shunt 105. The tip 4205 may be shaped atraumatically, such as with a rounded end. The tip 4205 may be made of a softer material than the rest of the shunt or may be made of the same material. The atraumatic tip 4205 is adapted to protect against corneal damage in the event of corneal contact or micromovement of the shunt. In one embodiment, at least a portion of the shunt includes a silicone sleeve that at least partially covers the outer surface of the shunt. The silicone sleeve can be formed by immersing the shunt in a silicone solution.

[0312] Figure 38 shows another embodiment in which the shunt 105 includes a resilient region 4305. The resilient region can be formed in various ways. For example, in one embodiment, the resilient region is formed by a reinforced region of silicone tubing or by a separate resilient element such as a spring. In another embodiment, the resilient region 4305 is corrugated to provide flexibility. The spring can be formed from various materials, including polyimide and stainless steel. Any of the embodiments of the shunt described herein may include a resilient region along a portion of its length or may be resilient along its entire length. Furthermore, the shunt may be flexible along its entire length, may have a predetermined stiffness along its entire length, or may have a stiffness that varies along its length.

[0314] As discussed earlier with reference to Figures 22 and 23, the shunt can be formed without an internal lumen and configured so that flow occurs along the outer surface of the shunt. Figure 39 shows another embodiment of a shunt 105 that does not have an internal lumen. The shunt 105 has a plurality of extensions 4405 that extend radially outward from a central core. The extensions 4405 define elongated slits that extend along the length of the shunt. The elongated slits serve as flow pathways to guide fluid flow along the shunt. The embodiment in Figure 39 has four extensions, although the number of extensions may vary. A material, such as silver, may be placed or coated within the slits to keep the channels open and provide an increased distribution area for fluid flow. As mentioned, the silver serves to inhibit or prevent tissue growth.

[0316] As shown in Figure 40A, the peripheral edges of the extensions 4405 may have slits or other structures adapted to retain or anchor the shunt within the eye. In the embodiment shown in Figure 40B, the shunt 105 has extensions 4405 and a central core with an internal lumen 4407 that can be used to mount the shunt in an insertion device. The central lumen 4407 can also be used for fluid flow through the shunt.

[0318] The shunt may include features adapted to modify or enhance fluid flow through or along the shunt, such as after the shunt has been placed in the eye. In one embodiment, shown in Figure 41, the shunt 105 has one or more orifices 4605 that communicate with the internal lumen. The orifices are initially plugged with a material such that no flow can occur through them. After the shunt is placed in the eye, the orifices can be unplugged, such as by inserting an instrument through them or by applying energy to the location where the orifices will form. The orifices can also be automatically unplugged by plugging them with a material that degrades upon placement in the eye or that degrades after a period of time.

[0320] Figure 42A shows a cross-sectional view of a portion of another embodiment of shunt 105. In this embodiment, shunt 105 includes a constricted region 4705 such that the internal lumen 4710 is at least partially blocked within the constricted region 4705. As shown in Figure 42B, the constricted region 4705 can be opened or expanded at a desired time, such as by applying heat to the constricted region 4705 to cause it to expand so that the internal lumen is no longer blocked. If desired, the region can be constricted again by applying more heat. The constricted region can also be opened and closed by tying a biodegradable band or suture around it. The sutures may erode over time, so that the constricted region gradually opens.

[0322] Figure 43 shows another embodiment of the branch 105 that includes one or more valved regions 4907 along the length of the branch. The valved regions 4907 serve to regulate fluid flow through the internal lumen. Each valved region 4907 may include a separate valve structure or may have a shape that regulates fluid flow. For example, the valved regions may be enlarged to allow greater fluid flow or reduced in size to limit fluid flow. The valved regions may be colored to respond to different colors of laser light depending on the desired result.

[0324] Figure 44 shows an embodiment of the bypass 105 that includes a bulbous element 4905 that is radially larger than the rest of the bypass. The bulbous element 4905 may be fixed in the enlarged state or may be adapted to change from a reduced-size state to an enlarged-size state. For example, the bulbous element 4905 may be an expandable balloon or an expansion member 910 as described above in Figure 9A. The bulbous element 4905 may include orifices that communicate with the internal lumen of the bypass 105 to allow fluid to enter and exit.

[0326] Figure 45 shows another embodiment of lead 105 in which the bulbous element 4905 is located between the proximal and distal ends of lead 105. Thus, lead 105 includes a central bulbous element 4905 with proximal and distal regions of reduced radial size relative to the bulbous element. Lead 105 may also include a plurality of bulbous elements interspersed along the length of the lead.

[0328] The use of shunt 105 with bulbous element 4905 is described below with reference to Figures 46 and 47, which show two embodiments of the bulbous element shunt positioned in the suprachoroidal space (SS). As shown in Figures 46 and 47, shunt 105 is positioned so that one proximal end communicates with the anterior chamber (AC), and bulbous element 4905 is positioned in the suprachoroidal space. The enlarged bulbous region 4905 forms a space or "lake" for fluid accumulation within the suprachoroidal space. Because the lake is contained entirely within the suprachoroidal space and surrounded by tissue, it is not prone to infection or other complications. The lake can also be formed using an embodiment of the shunt that does not have a bulbous element. Fluid can flow into the suprachoroidal space through the internal lumen of the shunt. The fluid accumulates within the suprachoroidal space to form the lake.

[0330] In another embodiment, the lake is formed by hydrodissection. An insertion cannula can be placed in the eye so that fluid can flow into the suprachoroidal space through the cannula. The fluid flows into the eye with sufficient pressure to form a dissection plane within the suprachoroidal space. The fluid can then accumulate within the suprachoroidal space so that a lake is formed.

[0332] Figure 48 shows an embodiment of shunt 105 that includes a distal tip member 5305 integrally formed with the shunt. The tip member 5305 is shaped to facilitate dissection in the suprachoroidal space. For example, the tip member 5305 may be bullet-shaped, in which the diameter of the tip member 5305 gradually decreases as it extends distally. The tip member 5305 may include one or more holes communicating with the internal lumen of the shunt. Alternatively, the tip member 5305 may be holeless, and the holes may be located on the side of the shunt 105. The tip member 5305 may be made of various materials, including stainless steel.

[0334] Figure 49 shows an embodiment of a shunt 105 mounted on a mandrel 5405, which may be a portion of the applicator 525 such that the mandrel 5405 can be incorporated into the delivery system. The shunt 105 is adapted to conform to the shape of the mandrel 5405 when mounted on the mandrel, such as during insertion of the shunt 105. When the mandrel 5405 is removed, the shunt 105 changes to a different shape. The shunt 105 may be made at least partially of a shape-memory material to achieve the shape change. In one embodiment, one or more Nitinol rings are arranged in the shunt, wherein the rings undergo a shape change to induce the shape transition of the shunt. Alternatively, a Nitinol wire may be passed along the length of the shunt to induce the shape change.

[0336] Different regions of shunt 105 may have different shapes. For example, shunt 105 may include a proximal region 5410 that is substantially round when mandrel 5405 is positioned within the shunt. When mandrel 5405 is removed from the shunt, the proximal region 5410 is reduced radially in size while the rest of the shunt retains its shape, as shown in Figure 50. The proximal region 5410 may be reduced in size when the mandrel is removed to limit or measure flow through the shunt. In addition, the proximal tip of the shunt may be flattened into an oval shape while the rest of the shunt remains round. Alternatively, the proximal tip may remain round but with a reduced diameter relative to the rest of the shunt.

[0338] When the mandrel is removed, the shunt 105 can assume a shape that is particularly suitable for placement and administration in the suprachoroidal space. For example, with reference to Figure 51A, the shunt 105 may include a first region 5605 that transitions to a first contour or first radius of curvature and a second region that transitions to a second contour or second radius of curvature. Figure 52 shows the shunt of Figure 51 placed in the eye. The first region 5605 has a first radius of curvature that complements the radius of curvature of the suprachoroidal space. The second region 5610 has a second radius of curvature that is narrower than the first radius, so that the proximal tip of the shunt is directed away from the cornea C and toward the anterior chamber AC. This reduces the likelihood of the proximal tip of the shunt 105 coming into contact with the cornea after shunt placement.

[0340] Figure 51B shows another embodiment of a clamp-shaped branch 105. The branch 105 includes a pair of legs 5615a and 5615b connected by a connecting member 5620. In one embodiment, both legs 5610 have an internal lumen with a distal opening 5625 for fluid inlet or outlet. The legs 5615 also have one or more proximal openings. The proximal openings may be located where the legs connect to the connecting member 5620. Alternatively, the connecting member 5620 may also have an internal lumen communicating with the internal lumens of the legs 5615. The connecting member 5620 may include one or more openings communicating with the internal lumens for fluid inlet or outlet. In another embodiment, only one of the 5615 legs has an internal lumen while the other leg is solid and serves as an anchoring member.

[0342] In use, shunt 105 of Figure 51B is positioned in the eye such that the distal opening 5625 of each leg 5615 communicates with the suprachoroidal space and the connecting member is positioned in the angle between the iris and the cornea. One or both legs 5615 provide a fluid passage between the suprachoroidal space and the anterior chamber. If one of the legs 5615 does not include an internal lumen, then the lumenless leg can serve as an anchor securing shunt 105 in a fixed position in the eye.

[0344] Figure 51C shows another embodiment of a shunt 105. This embodiment includes a partially annular connecting member 5640 and a plurality of legs 5645. The connecting member 5640 is partially annular because it extends over a range of less than 360 degrees. For example, the connecting member 5640 may extend from approximately 20 degrees to more than 180 degrees. The connecting member 5640 and the legs 5645 collectively reside within a curved plane that conforms to the curvature of a dissection plane that includes the suprachoroidal space. One or more of the legs 5645 may include an internal lumen that communicates with inlet and outlet openings. In use, the shunt 105 of Figure 51C is placed in the eye so that the connecting member 5640 sits within the angle between the iris and cornea, while the legs 5645 extend into the suprachoroidal space. The legs 5645 can serve as fluid conduits and/or as anchors to secure the device in the eye.

[0346] Additional description of the methods

[0348] There are several approaches to shunt delivery into the eye using a delivery system such as the one shown in Figure 6B. Figure 53 shows a schematic frontal view of the upper facial region of a patient, including both eyes. For reference, the eyes are shown divided into four quadrants, I, II, III, and IV, when viewed from the front of the eye. For each eye, quadrants I and III are located on the lateral side of the eye, and quadrants II and IV are located on the medial side. In one embodiment, the approach path passes through only one quadrant. In other embodiments, the path passes through at least two quadrants, at least three quadrants, or all four quadrants. In one illustrative embodiment of shunt insertion, the surgeon inserts the shunt by initially approaching the shunt to the eye from quadrant I or IV, so that the corneal incision is within quadrant I or IV. In another embodiment of shunt insertion, the shunt is approached from quadrant II or III. As described below, the location where the shunt is implanted in the suprachoroidal space can vary relative to the incision location. In one embodiment, the shunt implant location in the suprachoroidal space is from 0 to 180 degrees from the incision location. For example, the incision may be in quadrant I and the implant location is 180 degrees away in quadrant III. In another embodiment, the incision location and the implant location are separated by at least 90 degrees or up to 90 degrees. The actual placement of the shunt can be in any quadrant depending on the shape of the applicator tip.

[0350] Figures 54A and 54B show perspective and plan views, respectively, of an exemplary insertion pathway 5701 of the applicator and shunt during shunt implantation in the eye. The insertion pathway 5701 begins at an incision location 5702 and moves toward the dissection location 5703 where the shunt dissects the scleral spur and approaches the suprachoroidal space.

[0352] In one embodiment, the location of incision 5702 is along the axis separating quadrants I and IV (i.e., at the "9 o'clock" or "3 o'clock" position of the eye), and the dissection location 5703 is approximately 90 degrees to the incision location (i.e., at the "12 o'clock" position of the eye). This insertion route is transcorneal, i.e., it passes through the cornea. However, the insertion route need not be transcorneal. Figures 55A to 55D show the delivery system and attached shunt traveling along the insertion route described above. In Figure 55A (front plan view) and Figure 55B (perspective view), the delivery system 515 is in an initial approach position relative to the eye such that the distal end of the applicator 525 is in the incision and about to penetrate the eye. If the 525 applicator is curved, the curvature line of the 525 applicator can have various orientations. In one embodiment, the curvature line of the applicator is initially oriented so that the curvature points away from the inside of the eye.

[0354] With reference now to Figure 55C (front plan view) and Figure 55D (perspective view), the applicator and shunt have passed over the cornea such that the distal tip of the applicator has passed through the anterior chamber and is at or near the scleral spur. During this passage, the handle of the delivery system rotates and translates to align the curvature of the applicator with the curvature of the suprachoroidal space. The tip of the applicator 525 is then advanced and passed through the scleral spur to place the shunt 105 within the suprachoroidal space.

[0356] Figure 56 shows an alternative transcorneal insertion pathway 5701 in which the incision location 5702 and the dissection location 5703 are approximately 180 degrees apart. Figures 55A, 55B, and 57 show the delivery system and attached shunt that travels along this insertion pathway. In the initial approach orientation, the delivery system 510 is positioned so that the tip of the applicator 525 is at the incision location (as shown above in Figures 55A and 55B). The handle component 515 is translated and/or rotated approximately 90 degrees so that the distal tip of the applicator 525 lies within a plane that intersects the scleral spur. The curvature line of the 525 applicator is not yet necessarily aligned with the curvature of the eye in quadrant I. In addition, the applicator is still positioned in or near quadrant I.

[0358] With reference now to Figure 57, the delivery system 510 is translated so that the distal tip of the applicator 525 moves near or into quadrant IV. The translation can occur either by translating the handle component 510 or by extending the advancement member 530 and the applicator 525. Along with the translation, the handle component 510 is rotated to reorient the applicator 525 so that the line of curvature substantially aligns with the curvature of the eye, specifically the curvature of the dissection plane, which extends across the suprachoroidal space. At this stage, the tip of the applicator is directed toward the scleral spur, and the line of curvature extends into the suprachoroidal space. The applicator 525 can then be advanced distally into the suprachoroidal space, and the shunt can be dismounted from the applicator to position the shunt in or near quadrant IV.

[0360] As mentioned, the 510 delivery system can be approached to the eye in ways other than those described above. In another embodiment, the incision location and the dissection location are within the same quadrant. In this embodiment, the distal tip of the applicator passes through an incision in the cornea that is closer to the scleral spur, rather than from the eye as in the embodiments described above. Figures 58A to 58D show an example of such an insertion route. In Figure 58A (plan view) and Figure 58B (perspective view), the 510 delivery system is in an initial approach position (such as in quadrant I). The curvature line of the 525 applicator is not yet aligned with the curvature of the eye. The delivery system is then moved so that the 525 applicator penetrates the eye. The 510 handle component is then rotated so that the applicator faces the scleral spur and the line of curvature extends into the suprachoroidal space, as shown in Figure 58C (plan view) and Figure 58D (perspective view). The 525 applicator can then be advanced distally through the scleral spur and into the suprachoroidal space. The entire procedure was performed with the applicator positioned in a single quadrant. The 510 delivery system can be used for approaching the eye from various angles so that multiple 105 leads are placed around the circumference of the eye, as shown in Figure 58D. The 105 leads can be interleaved or grouped around the entire circumference or a portion of the circumference of the eye.

[0362] Another embodiment is one in which multiple leads are loaded into a delivery system and can be delivered to various locations around the anterior chamber up to the suprachoroidal space in such a way that the insertion device is not removed from the anterior chamber. The device moves along the anterior chamber and has a multi-firing chamber, so that when one lead is inserted from applicator 525, another lead is loaded into applicator 525, and so on. This allows multiple leads to be placed without having to reload or use another device.

[0364] Infusion

[0366] During the procedure, fluid may be infused into the eye to stabilize anterior chamber pressure, such as before, during, or after shunt placement. Infusion may also be used to maintain a clear field of vision along the insertion path during shunt insertion. There is a risk that anterior chamber pressure may drop adversely due to fluid loss, possibly resulting in anterior chamber collapse. To counteract a pressure drop, fluid may be infused into the anterior chamber to maintain pressure within a desired range. Fluid may be infused through a dedicated internal lumen in the applicator or through the lumen in the shunt. Fluid may also be infused through a separate system that interfaces with the eye. For example, a cannula limb may be inserted into the anterior chamber and connected to a fluid source, such as a saline bag or other biocompatible fluid source. If the pressure inside the anterior chamber falls below a threshold value, the resulting pressure difference can cause fluid to automatically flow into the anterior chamber through the cannulated limb.

[0367] A dye can be infused into the eye to provide visualization. The dye can be viewed through a visualization instrument. As the dye flows into the suprachoroidal space, it provides a visualization of the flow. The dye can be photoactivated so that it shows scattering of the aqueous humor when a certain type of light is applied to the dye. In addition, ultrasound or Doppler (for example, by integrating a Doppler tip into the insertion device) can be used to visualize or detect the flow, or the flow rate, through the suprachoroidal space.

[0369] Shunts in use with closed-angle glaucoma

[0371] With reference to Figure 59, it is possible for aqueous humor to accumulate within the posterior chamber PC such that at least a portion of the iris I is forced upward into the anterior chamber. Due to the pressure in the posterior chamber, the iris may tilt toward the cornea to form a ridge and then fall into the posterior chamber. In such a case, the base of the iris could interfere with or block the opening at the proximal end of the shunt. A shunt 105 with an elongated length or extension 6205 can be used to reposition the proximal end of the shunt 105 in a location that is not blocked or interfered with by the iris. For example, as shown in Figure 59, the extension 6205 is sized and positioned so that a proximal end 6210 is placed over the iris ridge. The extension 6210 may be made of a soft or flexible material to minimize or eliminate the risk of corneal damage if the proximal end 6210 comes into contact with the cornea. In another embodiment, shown in Figure 60, the extension 6205 has a curved shape so that the distal end 6210 is angled away from the cornea.

[0372] Figure 61 shows another embodiment in which the shunt extends through the iris I such that the proximal end 6210 and the internal lumen of the shunt communicate with the posterior chamber. The shunt allows aqueous humor to flow out of the posterior chamber to relieve pressure in the posterior chamber. The shunt 6205 can extend through various locations in the iris and can be fabricated from a flexible material, such as silicone. The embodiment shown in Figure 61 can be used instead of or in conjunction with an iris iridoplasty procedure. Furthermore, the delivery system can be adapted so that a distal end of the applicator has a tip, such as an RF tip as described in more detail above, that is adapted to perform iridoplasty without the use of the shunt.

[0374] Transscleral insertion of the shunt

[0376] In the embodiments described above, the 105 shunt is placed by passing it through a corneal incision or puncture. The surgeon then passes the shunt through the anterior chamber, through the scleral spur, and into the suprachoroidal space. In another embodiment, the surgeon makes an incision in the sclera to provide a transscleral insertion of the shunt into the eye. After making the scleral incision, the surgeon passes the proximal end of the shunt through the scleral incision into the suprachoroidal space. The surgeon then pushes the shunt into the anterior chamber, such as through the scleral spur, until the proximal portion of the shunt is in the anterior chamber and the distal portion of the shunt is in the suprachoroidal space.

[0378] The transscleral approach is described in more detail with reference to Figures 62 and 63. Figure 62 shows the insertion device 510 positioned so that the distal tip of the applicator 525 or the lead 105 itself can penetrate through an incision in the sclera. The incision can be made using the applicator 525 or the lead 105, or a separate cutting device can be used.

[0380] After the incision is formed, applicator 525 and the attached shunt are advanced through the sclera and into the suprachoroidal space. The surgeon advances applicator 525 until a proximal portion of shunt 105 is positioned within the anterior chamber and a distal portion is within the suprachoroidal space, as shown in Figure 63. The surgeon then releases shunt 105 from applicator 525 so that the shunt provides a fluid passage between the anterior chamber and the suprachoroidal space. In one embodiment, applicator 525 is advanced along a pathway from the suprachoroidal space toward the scleral spur so that the applicator crosses the scleral spur on its way to the anterior chamber. The 525 applicator can be preformed, steerable, articulated, or moldable to facilitate its passage through the suprachoroidal space along a suitable angle or path.

[0381] As discussed above, various devices can be used to help guide the insertion device and shunt to a suitable position in the eye. For example, a guide wire can be used to guide the applicator or shunt over the guide wire to the appropriate location in the eye. The guide wire or insertion device can be equipped with an optical fiber that provides direct visualization of the eye during shunt insertion. In another embodiment, one or more imaging systems can be used during device insertion. Such imaging systems may include, for example, ultrasound (UBM), optical coherence tomography (OCT), and endoscopic visualization. OCT performs cross-sectional imaging of the internal tissue microstructure by measuring the time delay of the backscattered infrared light echo using an interferometer and a low-coherence light source. For example, the Visante® OCT system from Zeiss Medical (Germany) can be used to obtain non-invasive images during implant placement or to confirm placement after the shunt is in place, both after the procedure and during follow-up. In addition, certain ultrasonic systems and those that provide enhanced tactile feedback or ultrasonic guidance can be used, such as the devices shown in U.S. patents 6969384 and 6676607. Endoscopes, such as the i-Scope™, and UBM (high-frequency ultrasound) devices, such as those manufactured by Ophthalmic Technologies, Inc. (Ontario, Canada), can also be used.

[0383] In another embodiment, the shunt is deployed in the eye in conjunction with a cataract treatment procedure. In a cataract treatment procedure, the surgeon makes an incision in the cornea and inserts a viscoelastic material into the eye through the incision. The surgeon then removes the cataract through the incision. In conjunction with this procedure, the surgeon implants a shunt 105 in the eye as described above. A new lens can then be implanted in the eye using this procedure. The shunt can be implanted before or after lens removal.

[0385] Although various embodiments of methods and devices are described in detail herein with reference to certain versions, it should be appreciated that other versions, embodiments, methods of use, and combinations thereof are also possible. Therefore, the scope of the appended claims should not be limited to the description of the embodiments contained herein.

Claims (11)

1. CLAIMS 1. An ocular implant system for reducing intraocular pressure in an eye, the system comprising: an elongated implant having a proximal end (110) and a distal end (120), wherein the elongated implant is configured to be inserted through an incision in a cornea and into an anterior chamber of the eye; and a delivery instrument (510) configured to be detachably attached to the implant, the delivery instrument comprising: (a) a handle component (515) having a longitudinal axis; (b) an elongated applicator (525) operatively coupled to the handle component, wherein the elongated applicator has an internal lumen and wherein the elongated implant is configured to be positioned within the internal lumen, the elongated applicator having a proximal region aligned with the longitudinal axis of the handle component and a distal region curved away from the longitudinal axis; and (c) an actuator (550) in the handle component of the delivery instrument arranged to retract the elongated applicator when the implant is placed; wherein the elongated applicator is configured to pass the implant through the anterior chamber into the scleral spur of the eye in the direction of the suprachoroidal space opposite the incision in the cornea; and wherein the elongated applicator is configured to position the implant, from inside the anterior chamber, in a first position such that the proximal end of the implant is in the anterior chamber, and the distal end communicates with the suprachoroidal space to provide a fluid passage between the suprachoroidal space and the anterior chamber, wherein the elongated applicator (525) is configured to retract to remove the implant; and characterized in that the implant is a porous member without a central internal lumen. 2. The system of claim 1, wherein the distal end of the implant has a sufficiently blunt shape so as not to penetrate the scleral spur or portion of scleral tissue. 3. The system of claim 1, wherein the applicator is configured to pass the implant from the anterior chamber beyond the scleral spur of the eye into the suprachoroidal space by penetrating the scleral spur. 4. The system of claim 3, wherein the distal end of the implant has a shape sufficiently sharp to penetrate the scleral spur. 5. The system of any preceding claim, wherein a distal tip of the applicator has an atraumatic shape. 6. The system of any preceding claim, wherein the implant and/or applicator is configured to create a dissection plane between a portion of a choroid and a portion of scleral tissue to expose the suprachoroidal space. 7. The system of claim 6, wherein the distal end of the implant is configured to create the dissection plane. 8. The system of claim 6, wherein a distal tip of the applicator is configured to create the dissection plane. 9. The system of any of claims 1 or 3, wherein a distal tip of the applicator has a sharp shape. 10. The system of claim 1, wherein a distal tip of the applicator is configured to penetrate the scleral spur as the applicator approaches the suprachoroidal space. 11. The system of any of claims 1, 3, 9 or 10, wherein a distal tip of the applicator is configured to penetrate the ciliary body as the applicator approaches the suprachoroidal space.